|Publication number||US5109851 A|
|Application number||US 07/650,961|
|Publication date||5 May 1992|
|Filing date||5 Feb 1991|
|Priority date||6 Feb 1989|
|Publication number||07650961, 650961, US 5109851 A, US 5109851A, US-A-5109851, US5109851 A, US5109851A|
|Inventors||Hossein Jadvar, William T. Metzger|
|Original Assignee||Arzco Medical Systems, Inc.|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (19), Non-Patent Citations (4), Referenced by (28), Classifications (17), Legal Events (11)|
|External Links: USPTO, USPTO Assignment, Espacenet|
This application is a continuation, of application Ser. No. 306,997, filed Feb. 6, 1989, now U.S. Pat. No. 5,069,215.
The invention pertains to noninvasive cardiac sensing or stimulating. More particularly, the invention pertains to an apparatus and a method for noninvasively pacing a subject's heart while simultaneously conducting for cardiac analysis.
It has been recognized that esophageal electrodes are particularly useful in connection with noninvasive esophageal pacing. One such electrode is disclosed for example in co-pending and commonly assigned U.S. patent application Ser. No. 930,748 entitled Improved Esophageal Electrocardiography Electrode.
It has also been recognized that transesophageal electrocardiography can be used for the purpose of studying myocardial ischemia. One such system is disclosed in commonly assigned and copending U.S. patent application Ser. No. 267,459 entitled Method and Apparatus For Detection of Posterior Ischemia.
It has also been recognized that transesophageal echocardiography can be utilized for the purpose of detecting or evaluating, among other conditions, myocardial ischemia. It would be desirable to be able to combine the pacing capability of esophageal electrodes and the sensing capability of echocardiography probes into a single unit so as to be able to stress the heart and to simultaneously study its characteristics
An apparatus and method are provided for esophageal heart pacing or heart monitoring. An apparatus in accordance with the invention has a flexible plastic sheet member. The sheet member, which can be generally of a rectangular shape, carries a plurality of spaced-apart electrode members.
A layer of adhesive is carried on the opposite side of the sheet member from the electrodes. Each of the electrodes is connected to one member of a plurality of insulated wires.
The insulated wires can be formed on an elongated MYLAR sheet member which is affixed at one end to the sheet member. At the other end of the elongated MYLAR sheet member is an electrical connector which is in turn connected to each of the conductors of the sheet member.
The electrical connector can in turn be coupled to a switch for selecting various pairs of electrodes. Outputs from or inputs to the selected pair of electrodes can be coupled to or received from an electrocardiograph or an esophageal pacing unit.
Signals from the esophageal pacing unit can be applied to the selected pair of electrodes for the purpose of noninvasively pacing the heart of the subject. Alternately, signals from the selected pair of electrodes can be provided to an amplifier for further processing for the purpose of driving electrocardiograph.
A method of esophageal pacing using a probe insertable into the esophagus of the subject includes the steps of affixing a disposable plurality of electrodes to the probe; positioning the probe in the esophagus; selecting at least one of the electrodes for pacing; and applying a selected electrical pacing signal to at least the selected electrode.
The present esophageal electrode is especially advantageous in that it can be manufactured as a single use element which can be affixed to a reusable probe prior to use. After use, the electrode unit can be discarded.
Alternately, the present multi-electrode structure could be permanently affixed to an esophageal probe. For example, the present electrode structure could be used with an esophageal ultrasonic probe.
Numerous other advantages and features of the present invention will become readily apparent from the following detailed description of the invention and the embodiments thereof, from the claims and from the accompanying drawings in which the details of the invention are fully and completely disclosed as a part of this specification.
FIG. 1 is a partial, side, schematic view of a subject illustrating the relationship between a probe in accordance with the present invention and the heart of the subject;
FIG. 2 is an enlarged portion of a probe carrying a multi-element electrode in accordance with the present invention;
FIG. 3 is an elevational view of one side of a disposable multi-electrode esophageal unit;
FIG. 4 is a second view of the disposable multi-electrode esophageal unit of FIG. 3;
FIG. 5 is a sectional view taken along plane 5--5 of FIG. 1; and
FIG. 6 is a pictorial diagram of an electrode selecting switch in accordance with the present invention.
While this invention is susceptible of embodiment in many different forms, there is shown in the drawing and will be described herein in detail a specific embodiment thereof with the understanding that the present disclosure is to be considered as an exemplification of the principles of the invention and is not intended to limit the invention to the specific embodiment illustrated.
FIG. 1 illustrates a subject S having a heart H and an esophagus E with a probe 10 positioned therein. The probe 10 carries a disposable esophageal electrode structure 12. The structure 12 is formed with a flexible medical grade plastic base member 20. The base member 20 carries a plurality of spaced-apart conducting elements 22-32 on a surface 20a.
Each of the elements 22-32 is formed of a biocompatible conducting material. Each of the elements 22-32 is permanently affixed to the base member 20. The base member 20 on a surface 20b opposite the surface 20a carries a layer of adhesive 34. The layer of adhesive 34 is used to affix the member 20 to the reusable probe 10.
The adhesive layer 34 can be formed of any biocompatible adhesive with adequate strength so as to fix the electrode structure 12 to the probe 10 for the length of any desired procedure. Subsequent to completion of the desired procedure, the electrode structure 12 is removed from the probe 10 and disposed of. The probe 10 can then be sterilized and reused.
A plurality of conducting members 36 is attached in a region 38 to the member 20. The plurality 36 can be formed with a plastic base member 39 on which is deposited a plurality of spaced apart conducting traces 36a-36f. Each of the traces, such as the trace 36a is electrically connected to a respective one of the conducting members 22-32, such as the member 22.
It will be understood that the details of the formation of the traces 36a-36f and the way in which those traces are carried by the plastic member 39 are not limitations of the present invention. Similarly, the details of how the traces 36a-36f interconnect with the conducting members 22-32 are also not a limitation of the present invention.
A second end of the plurality 36 carries an electrical connector 40 of a conventional variety. The connector 40 can be mated with a corresponding connector 42 which is carried by a multiple conductor cable 44. The cable 44 is in turn coupled to a manually operable switch 46.
The switch 46 could for example be implemented as a two-pole three position switch. It will be understood that the exact details of the switch 46 are not a limitation of the present invention. The switch 46 is used to manually select a pair of electrodes from the plurality 22-32. Output from the selected pair of electrodes, or input thereto, on a two-conductor cable 48 can be coupled to an ECG or received from an esophageal pacing unit 50.
The disposable multi-electrode element 12, in combination with the probe 10, makes it possible to combine cardiac pacing as a form of stress simultaneously with echocardiography to determine and sense heart function. For example, if the probe 10 is a transesophageal ultrasonic probe of a type marketed by Hoffrel Instruments, Inc., Model 482, the electrode structure 12 can be used for pacing the left atrium of the heart H. Simultaneously, an ultrasonic transmitter and receiver 52 on the probe 10 transmits ultrasonic waves toward the heart H and senses ultrasonic reflections therefrom for the purpose of forming an image of the cardiac chambers as the heart H is being simultaneously stimulated.
In a typical procedure, the sheet electrode member 12 is affixed to the perimeter of the probe 10 using the layer of adhesive 34. The electrode structure 12 is located at a level about 10 centimeters above the ultrasonic transmitter and receiver 52 in the probe.
The ultrasonic transmitter/receiver 52 is carried at a distal end of the probe 10. The multi-electrode element 12 is carried on the probe 10 adjacent the transmitter/receiver 52 but spaced therefrom.
The probe 10 is inserted in a conventional fashion into the esophagus E of the subject S. The electrode structure 12 is then connected via connectors 40, 42 to switch selector 46. The appropriate electrodes are selected and then either an esophageal preamplifier or a pacing unit is coupled to the cable 48 for sensing signals from or for pacing the heart H.
By way of example and not by way of limitation, the width of each of the electrode members 22-32 can be on the order of 7 millimeters with a corresponding spacing therebetween. The length dimension of the sheet member 20 can be on the order of 63 millimeters and the width dimension can be on the order of 40 millimeters.
The length of the plastic extension member 40, which could be formed of MYLAR can be on the order of 50 centimeters. The body member 20 can also be formed of a MYLAR sheet. It will be understood that any medical grade plastic could be used for the body member 20 without departing from the spirit and scope of the present invention.
Further, in a typical installation the switching unit 46 can be connected so as to switch as electrode pairs, electrodes 22, 32; 24, 30; or 24,26.
Alternately, the multiple electrode system 12 can be fabricated permanently attached to an imaging probe. Imaging probes, of the type discussed above, usually include an ultrasonic transmitter and receiver located at the end of the probe.
The transmitter is located in the esophagus below the heart and is oriented on the probe to transmit toward the heart. Reflected ultrasonic waves are detected by the transceiver, converted to corresponding electrical signals and transmitted from the probe to outside analysis circuitry.
Hence, it will be understood that the multiple electrodes 22-32 could be permanently attached to the body of the esophageal ultrasonic probe as generally indicated in FIG. 1.
From the foregoing, it will be observed that numerous variations and modifications may be effected without departing from the spirit and scope of the novel concept of the invention. It is to be understood that no limitation with respect to the specific apparatus illustrated herein is intended or should be inferred. It is, of course, intended to cover by the appended claims all such modifications as fall within the scope of the claims.
|Cited Patent||Filing date||Publication date||Applicant||Title|
|US3568660 *||20 Nov 1967||9 Mar 1971||Battelle Development Corp||Pacemaker catheter|
|US3734094 *||21 Jun 1971||22 May 1973||Calinog T||Multipurpose esophageal instrument|
|US3951136 *||7 Oct 1974||20 Apr 1976||Vital Signs, Inc.||Multiple purpose esophageal probe|
|US4176660 *||10 Mar 1978||4 Dec 1979||University Patents, Inc.||Disposable esophageal and tracheal multi-probes|
|US4319580 *||28 Aug 1979||16 Mar 1982||The Board Of Regents Of The University Of Washington||Method for detecting air emboli in the blood in an intracorporeal blood vessel|
|US4476872 *||12 May 1982||16 Oct 1984||The Kendall Company||Esophageal probe with disposable cover|
|US4640298 *||29 Jul 1985||3 Feb 1987||Peter Pless||Esophageal electrode probe useful for electrical stimulation of the heart|
|US4674518 *||6 Sep 1985||23 Jun 1987||Cardiac Pacemakers, Inc.||Method and apparatus for measuring ventricular volume|
|US4706681 *||13 Jun 1985||17 Nov 1987||Telectronics N.V.||Cardiac ultrasonically marked leads and method for used same|
|US4706688 *||26 Oct 1983||17 Nov 1987||Don Michael T Anthony||Non-invasive cardiac device|
|US4735206 *||7 Oct 1986||5 Apr 1988||Brunswick Manufacturing Co., Inc.||Method and apparatus for defibrillating and pacing the heart|
|US4762135 *||15 Nov 1985||9 Aug 1988||Puije P D V D||Cochlea implant|
|US4763660 *||13 Mar 1987||16 Aug 1988||Cherne Industries, Inc.||Flexible and disposable electrode belt device|
|US4817611 *||13 Nov 1986||4 Apr 1989||Arzco Medical Electronics, Inc.||Esophageal electrocardiography electrode|
|US4834102 *||25 Feb 1988||30 May 1989||Jack Schwarzchild||Endoscope for transesophageal echocardiography|
|US4852580 *||6 Nov 1987||1 Aug 1989||Axiom Medical, Inc.||Catheter for measuring bioimpedance|
|US4890623 *||14 Mar 1988||2 Jan 1990||C. R. Bard, Inc.||Biopotential sensing device and method for making|
|*||DE121090C||Title not available|
|*||DE133400C||Title not available|
|1||"A Pill Electrode For . . . Arrhythmia" J Med. Inst. 1978, by R. Arzbaecher.|
|2||"Use of the Pill Electrode . . . Pacing" by Jenkins et al, Journal PACE, 1985.|
|3||*||A Pill Electrode For . . . Arrhythmia J Med. Inst. 1978, by R. Arzbaecher.|
|4||*||Use of the Pill Electrode . . . Pacing by Jenkins et al, Journal PACE, 1985.|
|Citing Patent||Filing date||Publication date||Applicant||Title|
|US5154387 *||31 May 1990||13 Oct 1992||Syncromed Corporation||Method and apparatus for esophageal pacing|
|US5368496 *||10 Dec 1993||29 Nov 1994||Tetrad Corporation||Connector assembly having control lever actuation|
|US5387232 *||8 Oct 1992||7 Feb 1995||Synchrotech Medical Corporation||Method and apparatus for esophageal pacing|
|US5567328 *||8 Jun 1995||22 Oct 1996||The Whitaker Corporation||Medical circuit forming process|
|US5843132 *||7 Oct 1996||1 Dec 1998||Ilvento; Joseph P.||Self-contained, self-powered temporary intravenous pacing catheter assembly|
|US6266549||29 Jan 1999||24 Jul 2001||Heska Corporation||Apparatus and method for evaluating cardiac functions|
|US6322518||9 Feb 1998||27 Nov 2001||Heska Corporation||Method and apparatus for measuring cardiac output|
|US6438400||22 Feb 2000||20 Aug 2002||Heska Corporation||Electrode for evaluating cardiac functions via esophagus|
|US6779257 *||20 Feb 2001||24 Aug 2004||Volcano Therapeutics, Inc.||Method of making a flexible elongate member|
|US6882879||18 Jul 2001||19 Apr 2005||Innovamedica S.A. De C.V.||Impedance spectroscopy system and catheter for ischemic mucosal damage monitoring in hollow viscous organs|
|US7650183||19 Sep 2005||19 Jan 2010||Critical Perfusion, Inc.||Impedance spectroscopy system for ischemic mucosal damage monitoring in hollow viscous organs|
|US7676910 *||23 Aug 2004||16 Mar 2010||Volcano Corporation||Flexible elongate member having one or more electrical contacts|
|US7788139||25 Oct 2007||31 Aug 2010||TrailPay, Inc.||Methods and systems for an alternative payment platform|
|US8147486 *||23 May 2007||3 Apr 2012||St. Jude Medical, Atrial Fibrillation Division, Inc.||Medical device with flexible printed circuit|
|US8201327 *||5 May 2010||19 Jun 2012||Uppsala Lakarkonsult Ab||Multielectrode|
|US8221408||17 Jul 2012||St. Jude Medical, Atrial Fibrillation Division, Inc.||Medical device having integral traces and formed electrodes|
|US8430818 *||30 Apr 2013||Olympus Corporation||Capsule medical apparatus|
|US8610022 *||27 Dec 2011||17 Dec 2013||Emilio Sacristan Rock||Impedance spectroscopy system and catheter for ischemic mucosal damage monitoring in hollow viscous organs|
|US20020013537 *||18 Jul 2001||31 Jan 2002||Rock Emilio Sacristan||Impedance spectroscopy system and catheter for ischemic mucosal damage monitoring in hollow viscous organs|
|US20050015132 *||15 Apr 2004||20 Jan 2005||Itzhak Kronzon||Combined transesophageal echocardiography and transesophageal cardioversion probe|
|US20050091833 *||23 Aug 2004||5 May 2005||Kiepen Horst F.||Flexible elongate member having one or more electrical contacts|
|US20060015035 *||19 Sep 2005||19 Jan 2006||Rock Emilio S||Impedance spectroscopy system for ischemic mucosal damage monitoring in hollow viscous organs|
|US20070219551 *||23 May 2007||20 Sep 2007||Honour Kirk S||Medical device with flexible printed circuit|
|US20080004618 *||12 Jun 2007||3 Jan 2008||Michael Johnson||Medical device having integral traces and formed electrodes|
|US20080103356 *||25 Oct 2007||1 May 2008||Olympus Corporation||Capsule medical apparatus|
|US20100212155 *||5 May 2010||26 Aug 2010||Uppsala Lakarkonsult Ab||Multielectrode|
|US20120179018 *||27 Dec 2011||12 Jul 2012||Emilio Sacristan Rock|
|USRE44667||12 Apr 2007||24 Dec 2013||Critical Perfusion, Inc.|
|U.S. Classification||600/439, 607/10, 607/124, 600/462, 600/380|
|International Classification||A61B5/042, A61B8/12|
|Cooperative Classification||A61B8/445, A61B8/12, A61B2562/164, A61B2562/0209, A61B2562/043, A61B5/0422, A61B5/0421|
|European Classification||A61B8/12, A61B5/042D, A61B5/042B|
|24 Aug 1993||CC||Certificate of correction|
|15 Jun 1994||AS||Assignment|
Owner name: MARMON HOLDING, INC., ILLINOIS
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:ARZCO MEDICAL SYSTEMS, INC.;REEL/FRAME:007175/0171
Effective date: 19940615
|14 Nov 1995||FPAY||Fee payment|
Year of fee payment: 4
|14 Nov 1995||SULP||Surcharge for late payment|
|22 Nov 1999||SULP||Surcharge for late payment|
|22 Nov 1999||FPAY||Fee payment|
Year of fee payment: 8
|30 Nov 1999||REMI||Maintenance fee reminder mailed|
|19 Nov 2003||REMI||Maintenance fee reminder mailed|
|20 Nov 2003||REMI||Maintenance fee reminder mailed|
|5 May 2004||LAPS||Lapse for failure to pay maintenance fees|
|29 Jun 2004||FP||Expired due to failure to pay maintenance fee|
Effective date: 20040505